Senior Regulatory Affairs Specialist

1 day ago

mangalore, India beBeeRegulatoryAffairs Full time

Job Title: Regulatory Affairs SpecialistWe are seeking an experienced Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for managing regulatory submissions and ensuring compliance with global health authorities.The ideal candidate will have 8-10 years of experience in Regulatory Affairs, handling submissions across regulated and ROW markets. A strong understanding of global dossier formats, submission pathways, and lifecycle management is essential.Main Responsibilities:Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).Convert and prepare dossiers in multiple formats including eCTD, ACTD, and CTD.Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals).Coordinate responses to health authority queries through cross-functional collaboration and data collation.Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions.Project Planning & Management:Manage regulatory submissions for multiple products across multiple countries simultaneously.Utilize project management tools to track project milestones, timelines, and deliverables.Ensure efficient time and resource allocation to meet submission deadlines.Foster seamless communication between central regulatory, regional teams, and client stakeholders.Requirements:A minimum of 8-10 years of core experience in Regulatory Affairs, handling submissions across regulated and RoW markets.A strong understanding of global dossier formats, submission pathways, and lifecycle management.Excellent cross-functional communication and coordination skills.Proven ability to manage complex multi-country regulatory portfolios.About the Role:This role requires a highly skilled Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance with global health authorities. The ideal candidate will have a strong understanding of global dossier formats, submission pathways, and lifecycle management, as well as excellent cross-functional communication and coordination skills.What We Offer:We offer a competitive salary and benefits package to attract and retain top talent in the industry. Our company culture values innovation, teamwork, and customer satisfaction, making us an exciting place to work.

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